Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Propofol

Remifentanil

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Analgesics, Opioid

Narcotics

participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion

participants receive total intravenous anesthesia with remifentanil and propofol separately by two TCI pumps infusion

Participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump in intervention group. All TCI target concentration adjustments or extra bolus of propofol or remifentanil during operation were based on BIS and ANI monitor.

Remifentanil-propofol mixture

Zhi-Fu Wu, M.D.

Co-administration of propofol and remifentanil is considered to be an ideal total intravenous anesthesia technique, which is widely used in induction and maintenance of general anesthesia. Remifentanil and propofol can be mixed in polypropylene syringes for one hour with a remaining concentration of 91% in small concentrations of remifentanil. However, delivery of remifentanil-propofol mixture by target-controlled infusion(TCI) for general anesthesia in surgical procedure has not been described. Breast cancer surgery ( including modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure for patients with breast cancer with one-hour duration in our hospital. This pilot study was to examine the merit of remifentanil-propofol mixture as a GA regimen for breast cancer surgery.

Previous studies has described the feasibility and safety of remifentanil-propofol mixture use in sedation of pediatric patients undergoing magnetic resonance imaging or flexible fiberoptic bronchoscopy.

84 patients scheduled for breast cancer surgery were randomly allocated to receive TIVA with propofol and remifentanil separately by two TCI pump (Separate group) or with remifentanil-propofol mixture by single TCI pump (Mix group), all TCI concentration adjustments during operation were based on BIS and ANI monitor.

Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery

Use of a Remifentanil-propofol Mixture in Patients With Breast Cancer Undergoing Breast Cancer Surgery: a Prospective Pilot Study

measured by non-invasive blood pressure cuff

total consumption of remifentanil during procedure

total consumption of propofol during procedure

Tri-Service General Hospital

Resident physician

Nervous System Diseases

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Brain Neoplasms

Hyperlactatemia

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Metabolic Diseases

Fatma Özkan Sipahioglu

The investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.

Lactate level is one of the easy-to-measure parameters that are frequently used in anesthesia and intensive care clinical practice, especially to evaluate the severity of disease and the response to treatment. In patients with high lactate levels, the first considerations are hypoperfusion and sepsis. However, many causes such as trauma, seizures, ischemia, diabetic ketoacidosis, thiamine deficiency, malignancies, liver dysfunction, genetic disorders, toxins, drugs, etc. can be associated with increased lactate. Many tissues in the body can produce lactate. 25% of production is from muscle, 25% skin, 20% brain, 20% RBC and 10% bowel cells. Some malignancies, especially hematological cancers, have also been associated with increased lactate. In recent years, it has been reported that serum lactate levels are associated with the degree of glial tumor malignancy, and that lactate can even be used as a non-invasive malignancy biomarker in brain tumors. In a recent study, it was reported that the type of 'glioblastoma multiforme' among patients who underwent craniotomy with the diagnosis of intracranial brain tumor was an independent influencer factor for preoperative and postoperative hyperlactatemia. Anesthesia is one of the factors that can affect lactate levels due to its effect on systemic perfusion and the hepatic effects of anesthetic drugs. It looks like that there is no study in the literature on the effect of anesthesia technique on hyperlactatemia in patients who underwent craniotomy. Therefore the investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.

The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies

basal lactate level via arterial blood gas at the beginning of surgery

lactate level via arterial blood gas at one hour after the beginning of surgery

lactate level via arterial blood gas at three hour after the beginning of surgery

lactate level via arterial blood gas at the end of the surgery

Ankara Diskapi Training and Research Hospital

Principal Investigator, Anesthesiologist

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Prostatic Neoplasms

Respiratory Aspiration

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Platelet Aggregation Inhibitors

Sevoflurane

Anesthesia induction with intravenous propofol (effect site concentration 2.5 µg/mL) and remifentanil (effect site concentration 3 ng/mL) using target controlled infusion (TCI). Anesthesia maintenance with propofol effect site concentration 1.5\~4 µg/mL and remifentanil effect site concentration 2\~5 ng/mL.

Total intravenous anesthesia

Anesthesia induction with intravenous propofol bolus of 1.5\~2.5 mg/kg and remifentanil (effect site concentration 3 ng/mL)using target controlled infusion (TCI). Anesthesia maintenance with sevoflurane 1.5\~2.0 % and remifentanil effect site concentration 2\~5 ng/mL.

Inhalation Anesthesia

Robot-assisted laparoscopic radical prostatectomy (RALRP) has gained popularity during the past decade and has widely replaced conventional open prostatectomy in many institutions due to reduced blood loss, nerve sparing, less postoperative pain and shorter hospital stay. However, laparoscopic surgery is performed with intraperitoneal carbon dioxide insufflation, which leads to increased intraocular pressure (IOP). In particular, robot-assisted laparoscopic radical prostatectomy (RALRP) usually requires a steep Trendelenburg position and often prolonged insufflation times, which is known to effect the increase in IOP during surgery and may result in ophthalmic complications such as postoperative vision loss (POVL). The majority of patients undergoing RALRP is old aged and often present with comorbidities. Advanced age, underlying diabetes mellitus (DM) or hypertension renders the patient vulnerable to damage due to increased IOP. Moreover, the possibility of the patient having undiagnosed glaucoma is also increased, and therefore methods to prevent such complications are needed. As of now, intravenous hypnotic agents, inhalation anesthetics and opioids have been reported to decrease IOP by relaxing extraocular muscle tone and increasing aqueous humour outflow to some extent. Among these agents, propofol has been reported to be more effective than other inhalational anesthetics in decreasing IOP. The goal of this prospective, randomized controlled trial is to compare the effect of propofol and sevoflurane on IOP in patients undergoing RALRP in the steep Trendelenburg position with carbon dioxide pneumoperitoneum.

A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy

Before induction of anesthesia (T0), 5 minutes after induction of anesthesia (T1), 5 minutes after pneumoperitoneum (T2), 30 minutes after steep Trendelenburg position with pneumoperitoneum (T3), 5 minutes after returning to horizontal position with pneumoperitoneum (T4), 5 minutes after desufflation (T5), 5 minutes after awakening in the operating room (T6), 60 minutes after awakening in the recovery room (T7), 24 hours after the operation (T9)

Yonsei University

Respiration Disorders

Respiratory Tract Diseases

Anesthetics, Inhalation

induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery

propofol-based total intravenous anesthesia during breast cancer surgery

Valerii Subbotin, PhD

Kristina Kadantseva

Kristina Kadantseva, MD

Valery Likhvantsev, PhD

Even decade ago it was believed that the choice method of anesthesia did not affect the course of the oncological process, but recent evidence has begun to emerge that inhalation anesthesia vs TIVA is associated with a higher number of adverse outcomes. Apparently, it makes sense to conduct mRCT in order to assess the effect of IA on immune system in patients operated on for breast cancer comprehensively. The results of that kind of RCT may finally give us an answer whether the choice of anesthesia affects the immune status of patients undergoing surgery for breast cancer. The evaluation of complications and long-term survival will allow to recommend to use or not to use IA for this type of surgery.

Objective: The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery

The power calculation for this study was based on an assessment of Neutrophil-lymphocyte ratio (NLR) in patients undergoing breast cancer resection with total intravenous and inhalation anesthesia in two studies:

1. Cho J.S. et al., 2017 - 48 patients (PMID: 28924368, TIVA group: NLR = 3.37 ± 1.27; inhalation group: NLR = 3.85 ± 1.46)
2. Ní Eochagáin A. et al., 2018 - 116 patients (PMID: 29457215, TIVA group: NLR = 3.20 ± 1.37; inhalation group: NLR = 4.10 ± 1.90).

The pooled mean NLR in the TIVA group is 3.25±1.34, in the inhalation anesthesia group: 4.03±1.78.

Difference in means (effect size): 0.78, for level α=0.05, power 1-β=80% and expected standard deviation of 1.5, 65 patients in each group should be recruited, taking into account a 10% margin (total number of patients: 130).

The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial.

The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial (TeMP - Trial).

Absolute number of neutrophils divided by the absolute number of lymphocytes

the ratio of T helper cells to cytotoxic T cells

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery	NCT03817359	Anesthetics Remifentanil Propofol	Remifentanil-pr...	18 Years -	Tri-Service General Hospital
Use of a Remifentanil-propofol Mixture in Patients Undergoing Breast Cancer Surgery	NCT03817359	Anesthetics Remifentanil Propofol	Remifentanil-pr...	18 Years -	Tri-Service General Hospital
The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies	NCT05145049	Intracranial Ne... Hyperlactatemia Brain Tumor Hypoperfusion		18 Years -	Ankara Diskapi Training and Research Hospital
A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy	NCT01744262	Prostate Cancer	Total intraveno... Inhalation Anes...	20 Years - 70 Years	Yonsei University
The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies	NCT05145049	Intracranial Ne... Hyperlactatemia Brain Tumor Hypoperfusion		18 Years -	Ankara Diskapi Training and Research Hospital
A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy	NCT01744262	Prostate Cancer	Total intraveno... Inhalation Anes...	20 Years - 70 Years	Yonsei University
The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial.	NCT04800393	Anesthesia Breast Cancer	Sevoflurane Propofol	45 Years - 74 Years	Moscow Clinical Scientific Center
The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial.	NCT04800393	Anesthesia Breast Cancer	Sevoflurane Propofol	45 Years - 74 Years	Moscow Clinical Scientific Center

Spots Global Cancer Trial Database for total intravenous anesthesia